PRENATE CHEWABLE- calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin and bilberry tablet, chewable

Prenate Chewable by

Drug Labeling and Warnings

Prenate Chewable by is a Prescription medication manufactured, distributed, or labeled by Avion Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

A chewable Rx prenatal vitamin with a delicious chocolate flavor

Rx Only

DESCRIPTION

DESCRIPTION: PRENATE CHEWABLE ® is a prescription prenatal/postnatal multivitamin/mineral chocolate chewable tablet. Each tablet is brown and imprinted with "Prenate Chew" on one side and blank on the other.

INACTIVE INGREDIENT

OTHER INGREDIENTS: Chocolate Flavor, Gum Acacia, Fructose, Magnesium Stearate, Natural Dutch Chocolate, Silicone Dioxide and Silica (as Sipernat ®), and Hydrogenated Vegetable Oil (as Sterotex ®).

INDICATIONS & USAGE

INDICATIONS: PRENATE CHEWABLE ® is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE CHEWABLE ™ can also be beneficial in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

PRECAUTIONS

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician.

HOW SUPPLIED

HOW SUPPLIED: PRENATE CHEWABLE ® is supplied in child-resistant bottles of 30 tablets (75854-306-30).

The listed product number is not a National Drug Code, but has instead merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

STORAGE AND HANDLING

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

SPL UNCLASSIFIED SECTION

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

MANUFACTURED FOR: Avion Pharmaceuticals, LLC

Atlanta, GA 30350

1-888-61-AVION

*Quatrefolic ® is a registered trademark of Gnosis, SpA.Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1

Rev. 0619-05

PRINCIPAL DISPLAY PANEL

75854-306-30

Prenate chewable ®

A chewable Rx prenatal vitamin with a delicious chocolate flavor

with Quatrefolic®

Dietary Supplement

30 Tablets

Rx Only

Avion
PHARMACEUTICALS

INGREDIENTS AND APPEARANCE

PRENATE CHEWABLE 
calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin and bilberry tablet, chewable

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 75854-306
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	500 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	300 [iU]
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	50 mg
BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q)	BORON	250 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	125 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	280 ug
BILBERRY (UNII: 9P2U39H18W) (BILBERRY - UNII:9P2U39H18W)	BILBERRY	25 mg

Inactive Ingredients
Ingredient Name	Strength
FRUCTOSE (UNII: 6YSS42VSEV)
ACACIA (UNII: 5C5403N26O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	brown	Score	2 pieces
Shape	ROUND	Size	22mm
Flavor	CHOCOLATE	Imprint Code	PrenateChew
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75854-306-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/16/2013

Labeler - Avion Pharmaceuticals, LLC (040348516)

Establishment
Name	Address	ID/FEI	Business Operations
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-306)